RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Sponsors of medical device products containing radioactive material may soon find it easier to bring the products to market under a newly proposed rule issued this week by the Nuclear Regulatory Commission (NRC).

According to the NRC, byproduct materials are those made radioactive by exposure to nuclear material, created as waste or through extraction from other radioactive material, or created from naturally occurring radioactive material.

Such products are commonly used for medical applications, such as in nuclear medicine, brachytherapy and teletherapy. While the US Food and Drug Administration (FDA) has regulatory authority over the devices' approval, the NRC regulates the use of most of those devices (states generally regulate X-ray machines).

Among the numerous changes proposed by the NRC in its new rule are several related to medical devices. For example, Section 35.500, Use of Sealed Sources for Diagnosis, would permit already-registered diagnostic devices using "sealed sources" of radioactive material to be used in research "in accordance with an active investigational device exemption (IDE) application accepted by FDA." Previously, new investigations would require a sponsor to first seek a license amendment, NRC explained.

The rule applies only to diagnostic medical devices, and must still be used "in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry," the proposed regulation states.

The proposed rule also revises training requirements for users of a wide range of medical devices.